A Master Batch Record (MBR) in pharmaceutical manufacturing is an essential document that outlines detailed instructions, specifications, and procedures for producing specific products or batches. Acting as a master template, it standardises the manufacturing process to ensure consistency, compliance, and uniformity across batches. This includes formulation details, manufacturing steps, equipment needs, in-process controls, and quality assurance measures, making it crucial for regulatory adherence and maintaining the high quality and consistency of pharmaceutical products.
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